Nano-Crystalline Ceramic Coatings for the Reduction of Sliding Resistance of Orth

描述（由申请人提供）：这个小型企业创新研究项目旨在开发硬质陶瓷涂层，以减少正畸治疗过程中托槽中弓丝的滑动阻力。过度的滑动阻力是摩擦和缺口/绑定行为的结合，当托架沿着金属丝滑动到新的位置时，会阻碍牙齿的运动，导致难以预测的结果，并且需要增加力、治疗时间、“椅子时间”和患者费用。如果成功的话，硬涂层将会从弓丝材料的其他特性（如刚度）中分离出滑动阻力，并为医生提供新的材料系统来解决特定的患者问题。第二阶段将继续并扩展非常有前途的第一阶段的结果，其中通过离子束辅助沉积（IBAD）应用氧化铝，氧化锆和二氧化钛的薄涂层。在一家主要的正畸器具制造商进行的测试中，涂层决定性地降低了弓线的滑动阻力。测试表明，滑动摩擦和缺口/结合行为都有显著降低；其中两种涂层材料具有较高的抗刮擦和抗分层性。II期项目将通过优化IBAD参数来改善涂层性能，通过体外测试在更现实的配置下评估涂层弓丝，并最终选择涂层材料和沉积参数进行临床研究。涂层弓丝将在一所主要研究型大学的有限临床研究中进行评估，以测试其在儿童牙齿矫直的早期和中期阶段的功效。陶瓷涂层正畸弓线的商业化潜力非常高，我们的工业合作伙伴在实验室测试的第一阶段已经证明了这一点。第三阶段的商业化将是Spire Biomedical的涂层和表面改性业务的直接扩展，该业务专门从事骨科假体、导管和其他医疗设备的表面处理。

DESCRIPTION (provided by applicant): This Small Business Innovation Research project aims to develop hard ceramic coatings that will reduce the sliding resistance of archwires in their brackets during orthodontic treatment procedures. Excessive sliding resistance, which is a combination of friction and notching/binding behavior, works against tooth motion as the bracket slides along the wire into a new position, resulting in less predictable outcomes, and requiring increased force, treatment time, "chair time," and patient costs. If successful, the hard coatings will decouple sliding resistance from other properties of the arch-wire material, such as stiffness and provide the practitioner with new material systems for solving specific patient problems. Phase II will continue and expand highly promising Phase I results, in which thin coatings of alumina, zirconia, and titania were applied by ion beam assisted deposition (IBAD). The coatings decisively reduced sliding resistance of archwires in tests conducted by a major manufacturer of orthodontic appliances. The testing showed major reductions of both sliding friction and notching/binding behavior; and two of the coating materials demonstrated high resistance to scratching and delamination. The Phase II program will improve on coating properties through optimization of IBAD parameters, evaluate the coated archwires by in vitro testing in a more realistic configuration, and make a final selection of coating material and deposition parameters for a clinical study. Coated archwires will be evaluated in a limited clinica study at a major research university to test their efficacy in early and intermediate stages of tooth straightening in children. The commercialization potential of ceramic-coated orthodontic archwires is very high, as already demonstrated by the Phase I involvement by our industrial collaborators in laboratory testing. Phase III commercialization would be a straightforward expansion of Spire Biomedical's coating and surface- modification business, which specializes in surface treatments for orthopedic prostheses, catheters, and other medical devices.